TABLE OF CONTENTS Successful installation and implementation of a CDS requires effectively trained users using good documented procedures. Vendor documentation also provides reference material that will be outside the scope of standard operating procedures (SOPs). Together these contribute to the controlled function elements of computerised system validation described in Figure 9.
Clause 127 states:
It is essential that there is the closest co-operation between key personnel and those involved with computer systems. Persons in responsible positions should have the appropriate training for the management and use of systems within their field of responsibility, which utilises computers. This should include ensuring that appropriate expertise is available and used to provide advice on aspects of design, validation, installation and operation of computerised system.
211.25 Personnel Qualifications (a)12:
Each person engaged in the manufacturing, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee s functions.
(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
Section 58.29 Personnel14:
Each individual engaged in...
